Cigna Drug and Biologic Coverage Policy

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Cigna Drug and Biologic Coverage Policy"

Transcription

1 Cigna Drug and Biologic Coverage Policy Subject Implantable Hormone Pellets Table of Contents Coverage Policy... 1 General Background... 3 Coding/Billing Information... 5 References... 6 Effective Date... 2/15/2018 Next Review Date... 2/15/2019 Coverage Policy Number Related Coverage Resources Compounded Medications Infertility Services Male Sexual Dysfunction Treatment: Non- Pharmacologic Testosterone Therapy INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Proprietary information of Cigna. Coverage Policy Implantable hormone pellets include the following: FDA approved Testopel (testosterone pellets) Compounded testosterone pellets Compounded estrogen and estrogen derivative pellets (for example, estradiol, estriol, estrone) Compounded progesterone and progesterone derivative pellets (for example, progestin) Cigna covers Testopel (testosterone pellets) as medically necessary in males when either of the following criteria is met: Diagnosis of hypogonadism or hypogonadotropic hypogonadism (congenital or acquired) in an individual 18 years of age or older as confirmed by BOTH of the following: o Documentation of signs and symptoms of androgen deficiency o Two early morning, low total serum testosterone levels drawn on different days. Low serum testosterone level is defined as ANY of the following: Below the laboratory s normal reference range Total testosterone level less than 280 ng/dl (9.7 nmol/l) Free testosterone level less than 5 pg/ml (0.17 nmol/l) Diagnosis of delayed puberty in an individual 14 years of age or older as confirmed by BOTH of the following: o Documentation of limited or no signs of puberty o Testosterone is being used short term (4 to 6 months) to stimulate puberty Initial approval quantity limit is 6 pellets per 90 days. Page 1 of 7

2 Quantities beyond 6 pellets per 90 days require: Documentation of continued signs and symptoms of androgen deficiency Documentation of a persistent early morning, low testosterone level. Low serum testosterone level is defined as ANY of the following: o Below the laboratory s normal reference range o Total testosterone level less than 280 ng/dl (9.7 nmol/l) o Free testosterone level less than 5 pg/ml (0.17 nmol/l) Cigna does not cover Testopel (testosterone pellets) for any other indication including the following because it is considered experimental, investigational or unproven. Treatment of menopausal symptoms Cigna does not cover compounded testosterone pellets for any indication because they are considered experimental, investigational or unproven. Cigna does not cover implantable estrogen/estrogen derivative pellets (either estrogen/estrogen derivative alone or in combination with testosterone) or implantable progesterone/progestin pellets for treatment of menopausal symptoms or any other indication because they are considered experimental, investigational or unproven. When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to Testopel (testosterone pellets). Note: Receipt of sample product does not satisfy any criteria requirements for coverage. FDA Approved Indication (There are no FDA-approved, commercially available formulations of implantable estrogen or progesterone/progestin pellets.) MALES Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy. Hypogonadotrophic hypogonadism (congenital or acquired) - idiopathic or gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation. If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. The safety and efficacy of Testopel (testosterone pellets) in men with age-related hypogonadism (also referred to as late-onset hypogonadism ) have not been established. Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An x-ray of the hand and wrist to determine bone age should be taken every 6 months to assess the effect of treatment on epiphyseal centers. FDA Recommended Dosing Page 2 of 7

3 (There are no FDA-approved, commercially available formulations of implantable estrogen nor or progesterone/progestin pellets.) Prior to initiating Testopel (testosterone pellets), confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. The suggested dosage for androgens varies depending on the age, and diagnosis of the individual patient. Dosage is adjusted according to the patient s response and the appearance of adverse reactions. The dosage guideline for the testosterone pellets for replacement therapy in androgen-deficient males is 150mg to 450mg subcutaneously every 3 to 6 months. Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower doses initially, gradually increasing the dose as puberty progresses, with or without a decrease in maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. Dosages in delayed puberty generally are in the lower range of that listed above and, for a limited duration, for example 4 to 6 months. The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate determined by a gradual reduction of the amount administered parenterally. The usual dosage is as follows: implant two 75 mg pellets for each 25 mg testosterone propionate required weekly. Thus when a patient requires injections of 75 mg per week, it is usually necessary to implant 450 mg (6 pellets). With injections of 50 mg per week, implantation of 300 mg (4 pellets) may suffice for approximately three months. With lower requirements by injection, correspondingly lower amounts may be implanted. It has been found that approximately one-third of the material is absorbed in the first month, one-fourth in the second month and onesixth in the third month. Adequate effect of the pellets ordinarily continues for three to four months, sometimes as long as six months. Drug Availability (There are no FDA-approved, commercially available formulations of implantable estrogen nor or progesterone/progestin pellets.) Each testosterone pellet contains 75 mg testosterone, one individual pellet per vial. Testosterone pellets are classified as a Schedule III controlled substance under the Anabolic Steroids Act of General Background Pharmacology Endogenous androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution such as beard, pubic, chest and axillary hair, laryngeal enlargements, vocal cord thickening, alterations in body musculature and fat distribution. Drugs in this class can also cause retention of nitrogen, sodium, potassium, phosphorus, and decreased urinary excretion of calcium. Androgens are responsible for the growth spurt of adolescence and for the eventual termination of linear growth which is brought about by the fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause a disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of growth process. Androgens have been reported to stimulate the production of red blood cells by enhancing the production of erythropoietic stimulating factor. During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH). Clinical Efficacy Page 3 of 7

4 Testopel received FDA approval in 1972 when labeling requirements were less stringent, and as such, there is no clinical efficacy information available in the current label. FDA Warning As of October 2016, the FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS. The Anabolic Steroids Control Act of 1990 placed AAS, including testosterone, in Schedule III of the Controlled Substances Act. Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia. The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/aas abuse. In addition to the new Warning, all testosterone labeling has been revised to include information in the Abuse and Dependence section about adverse outcomes reported in association with abuse and dependence of testosterone/aas, and information in the Warning and Precautions section advising prescribers of the importance of measuring serum testosterone concentration if abuse is suspected. Prescription testosterone products are FDA-approved as hormone replacement therapy for men who have low testosterone due to certain medical conditions. Examples of these conditions include failure of the testicles to produce testosterone because of genetic problems, or damage to the testicles from chemotherapy or infection (FDA, 2016). Guidelines Diagnosis of androgen deficiency should include a comprehensive health examination in order to rule out other diseases and use of medications that may impact testosterone synthesis or metabolism. Differences in measurement and intermittent secretion are factors which also effect serum testosterone levels. In addition, testosterone levels are impacted by circadian rhythms where the highest levels occur in the morning. Taking these elements into account, the Endocrine Society recommends obtaining a morning total testosterone level and verification of the results with an additional sample. For individuals with total testosterone levels in the lower range of normal, obtaining a free or bioavailable testosterone level is advised. Individuals should refrain from these lab measurements during periods of illness. To differentiate between primary and secondary hypogonadism, LH and FSH levels are suggested (Bhasin, 2010). In treating adult males with hypogonadism, current guidelines suggest a preference for prescribing intramuscular or topical testosterone agents over the oral formulations (tablets or capsules) due to the unsatisfactory androgen effects and side effect profile of the oral route. Deciding which particular testosterone therapy to use should be made by the physician and a well- informed patient, taking into consideration factors such benefits versus risks, patient preferences, and pharmacokinetics of the drug formulation. Individuals should be monitored for response to treatment, adverse events and discontinued if there is no response. Although the guidelines suggest initiating therapy with a short-acting formulation, they are silent regarding preference for either topical or injectable testosterone formulations. In regards to adverse events, use of the long acting injectable form could be problematic because of the prolonged wash out period (Bhasin, 2010; Dohle 2015; Petak, 2002; Wang, 2009). The Endocrine Society Task Force on androgen therapy in women considers androgen deficiency syndrome in healthy women to not be clearly understood and further data is needed. Under these circumstances they do not recommend diagnosis of the syndrome in a healthy female. In general, the Task Force does not recommend the use of testosterone therapy for infertility, cognition, cardiovascular indications, bone health or general wellbeing. In regards to sexual dysfunction, the group suggests testosterone use should be limited to use in hypoactive sexual desire disorder (HSDD), where evidence demonstrates short-term efficacy and safety of the use of high physiologic dosing of testosterone in the postmenopausal woman with HSDD. Due to the paucity of Page 4 of 7

5 data regarding the safety and efficacy of dehydroepiandrosterone (DHEA), the Task Force does not endorse its routine use (Wierman, 2014). In their Menopause Position Statement, The North American Menopause Society (NAMS, 2012) cites the health risks associated with use of custom compounded bio-identical hormone therapy. NAMS states that in the majority of individuals, an FDA approved hormone replacement is sufficient and avoids the risks associated with compounded preparations. The organization further states it only recommends compounded estrogen replacement therapy in order to avoid allergic reactions to ingredients in FDA approved products (Gass, 2012). The American Association of Clinical Endocrinologists (AACE) Medical Guidelines for the Clinical Practice for the Diagnosis and Treatment of Menopause do not support the use of compounded bio-identical hormone therapy (Goodman, 2011). The Endocrine Society has commented that no published studies in peer-reviewed literature demonstrate compounded bio-identical hormone products are more safe or efficacious than FDA approved products. The organization also calls attention to the lack of quality control and safety and efficacy data for compounded preparations. The Society recommends treatment with FDA approved products and does not recommend use of compounded hormone formulations (Stuenkel, 2015; Santen, 2010). Quantity Limitations FDA recommended dosing supports a quantity limitation of 24 pellets per year while lower level evidence reported in observational and pharmacokinetic studies may indicate a higher quantity (e.g., up to 44) per year (McCullough 2012, Pastuszak 2012). Professional society guidelines do not indicate a specific number of pellets but do suggest an implantation interval of every 3 to 6 months (Bhasin, 2010). Experimental, Investigational, Unproven Uses Menopausal women may have lower levels of some hormones and experience hot flashes, vaginal dryness, and thin bones. Some physicians prescribe hormones to treat these symptoms, such as estrogen or estrogen with a progestin or progesterone, and some may be compounded and called bio-identical. The term bio-identical has no defined meaning in any medical or conventional dictionary, and FDA does not recognize the term. In addition, different medical groups define the term differently. Some compounding pharmacies use bio-identical as a marketing term to imply that drugs are natural, or have effects identical to those from hormones made by the body. FDA is not aware of credible scientific evidence to support these claims. Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits and risks associated with FDA-approved hormone therapy. Compounded drugs can pose both direct and indirect health risks. Direct health risks include unsafe compounded products. Compounded drugs may be unsafe and compounded drugs made using poor quality compounding practices may be sub- or super-potent, contaminated, or otherwise adulterated. Indirect health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective. FDA has approved drugs for use in hormone therapy for menopause symptoms which include products containing only estrogen, products containing only progestin, and products containing estrogen and progestin. There are no FDA approved, compounded implantable hormone pellets. Coding/Billing Information Note: 1) This list of codes may not be all-inclusive. 2) Deleted codes and codes which are not effective at the time the service is rendered may not be eligible for reimbursement. Covered when medically necessary for indications outlined in the policy: CPT * Codes Description Page 5 of 7

6 11980 Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin) HCPCS Codes S0189 Description Testosterone pellet, 75 mg Note: Experimental/Investigational/Unproven/Not Covered when used to report subcutaneous implantation of compounded testosterone for any indication. Note: Experimental/Investigational/Unproven/Not Covered when used to report estrogen/estrogen derivative pellets (either estrogen/estrogen derivative alone or in combination with testosterone) or implantable progesterone/progestin pellets. Experimental/Investigational/Unproven/Not Covered when used to report implantable estrogen/estrogen derivative pellets (either estrogen/estrogen derivative alone or in combination with testosterone) or implantable progesterone/progestin pellets: HCPCS Codes J3490 J3590 Description Unclassified drugs Unclassified biologics *Current Procedural Terminology (CPT ) 2014 American Medical Association: Chicago, IL. References 1. American College of Obstetricians and Gynecologists (ACOG). Management of menopausal symptoms. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2014 Jan Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, et al. The Endocrine Society. Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010; 95(6): Accessed January 4, Dohle G, Arver S, Bettocchi C, et al. European Association of Urology Guidelines on Male Hypogonadism. March Available at: Accessed January 4, Endo Pharmaceuticals Inc. Testopel (testosterone pellets) package insert. Malvern, PA. October Accessed January 3, Food and Drug Administration (FDA) Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products. Last updated June 20, Available at: 6. Food and Drug Administration (FDA) on Menopause and Hormones: Common Questions. Last updated September 16, Available at: 7. Food and Drug Administration (FDA) on Compounded Menopausal Hormone Therapy Questions and Answers. Last updated February 5, Available at: htm. 8. Food and Drug Administration (FDA) Warning on the Abuse and Dependence Risks Associated with Testosterone and other Anabolic Androgenic Steroids. October 25, Available at: ource=govdelivery. 9. Finkle WD, Greenland S, Ridgeway GK, Adams JL Frasco MA, Cook MB, et al. Increase risk of nonfatal myocardial infarction following testosterone therapy prescription in men. PLoS One Jan 29; (9)(1). Page 6 of 7

7 10. Pinkerton JV, Aguirre FS, Blake J, et al. The North American Menopause Society (NAMS) Hormone Therapy Position Statement. Menopause: The Journal of the North American Menopause Society 2017; 24(7): Accessed January 4, Goodman NF, Cobin RH, Ginzburg SB, et al. American Association of Clinical Endocrinologists (AACE) Medical guidelines for clinical practice for the diagnosis and treatment of menopause. Endocr Pract. 2011; 17(Supp 6): McCullough A. A Review of Testosterone Pellets in the Treatment of Hypogonadism. Curr Sex Health Rep Oct; 6: McCullough AR, Khera M, Goldstein I, et al. A Multi-Institutional Observational Study of Testosterone Levels after Testosterone Pellet (Testopel ) Insertion. J Sex Med. 2012; 9: Pastuszak AW, Mittakanti H, Liu JS, et al. Pharmacokinetic evaluation and dosing of subcutaneous testosterone pellets. J Androl Sep-Oct; 33(5): Petak SM, Nankin HR, Spark RF, Swerdloff RS, Rodriguez-Rigau, LJ; American Association of Clinical Endocrinologists. Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hypogonadism in Adult Male Patients. Endocr Pract Dec; 8(6): Santen RJ, Allred DC, Ardoin SP, et al. Postmenopausal Hormone Therapy: An Endocrine Society Scientific Statement. The Journal of Clinical Endocrinology & Metabolism. 2010; 95(Supp 1):S1-S Stuenkel C, Davis S, Gompel A, et al. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. November 2015; 100(11): Accessed January 4, Vigen R, O Donnell CI, Baron AE, Grunwald GK, Maddox TM, Bradley SM, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013; 310(17): Wang C, Nieschlag E, Swerdloff RS, et al. Consensus Statement: Investigation, treatment, and monitoring of late-onset hypogonadism in males: ISA, ISSAM, EAU, EAA and ASA recommendations. Eur J Endocrinol. 2008; 159: Accessed January 4, Wierman ME, Wiebke A, Basson R, et al. Androgen Therapy in Women: A Reappraisal: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab Oct 2014:99; Accessed January 4, Cigna Companies refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. Copyright 2018 Cigna. Page 7 of 7

Testosterone Topical/Buccal/Nasal

Testosterone Topical/Buccal/Nasal BENEFIT APPLICATION Testosterone Topical/Buccal/Nasal DRUG POLICY Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations

More information

SUMMACARE COMMERCIAL MEDICATION REQUEST GUIDELINES TESTOSTERON. Generic Brand HICL GCN Exception/Other ROUTE MISCELL.

SUMMACARE COMMERCIAL MEDICATION REQUEST GUIDELINES TESTOSTERON. Generic Brand HICL GCN Exception/Other ROUTE MISCELL. Generic Brand HICL GCN Exception/Other ANDRODERM 01403 ROUTE MISCELL. ANDROGEL AXIRON FORTESTA NATESTO STRIANT TESTIM VOGELXO DEPO- 01400 ROUTE MISCELL. CYPIONATE TESTOSTERON E GCN 38586 DELATESTRYL 01401

More information

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare Pharmacy Clinical Pharmacy Programs UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2018-9 Program Prior Authorization/Medical Necessity Topical Androgens Medication Axiron*, Androderm, Androgel*, Fortesta*, Natesto*,

More information

See Important Reminder at the end of this policy for important regulatory and legal information.

See Important Reminder at the end of this policy for important regulatory and legal information. Clinical Policy: Reference Number: CP.CPA.291 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important regulatory

More information

Policy. covered: bilateral. alcohol or. Approve. 3. Palliative enanthate injection in. women for. 6 months if. can also sponsive tumor.

Policy. covered: bilateral. alcohol or. Approve. 3. Palliative enanthate injection in. women for. 6 months if. can also sponsive tumor. Injectablee Testosterone Products Prior Authorization Policy Number: 5.01.597 Origination: 07/2014 Last Review: 07/2014 Next Review: 07/2015 Policy BCBSKC will provide coverage for injectable testosterone

More information

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES Generic Brand HICL GCN Exception/Other METHYL ANDROID METHITEST METHYL TESTRED 01404 ROUTE MISCELL. CYPIONATE ENANTHATE GUIDELINES FOR USE ANDRODERM ANDROGEL AXIRON FORTESTA NATESTO STRIANT TESTIM VOGELXO

More information

Medication Policy Manual

Medication Policy Manual Independent licensees of the Blue Cross and Blue Shield Association Medication Policy Manual Topic: Non-preferred, non-transdermal testosterone replacement therapy products (Android, Aveed, Androxy, Methitest,

More information

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

Medical Policy An independent licensee of the Blue Cross Blue Shield Association Androgens and Anabolic Steroids Page 1 of 57 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Androgens and Anabolic Steroids Prime Therapeutics will review Prior

More information

Testosterone Hormone Replacement Drug Class Prior Authorization Protocol

Testosterone Hormone Replacement Drug Class Prior Authorization Protocol Line of business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 Testosterone Hormone Replacement Drug Class Prior Authorization Protocol This policy has been developed through

More information

Androgens and Anabolic Steroids Prior Authorization with Quantity Limit - Through Preferred Topical Androgen Agent

Androgens and Anabolic Steroids Prior Authorization with Quantity Limit - Through Preferred Topical Androgen Agent Androgens and Anabolic Steroids Prior Authorization with Quantity Limit - Through Preferred Topical Androgen Agent Androgens/Anabolic Steroids Prior Authorization with Quantity Limit Through Preferred

More information

Issues. What is a low testosterone? Who needs testosterone therapy? Benefits/adverse effects of testosterone replacement Treatment options

Issues. What is a low testosterone? Who needs testosterone therapy? Benefits/adverse effects of testosterone replacement Treatment options Male Hypogonadism Jauch Symposium Waterloo, IA May 17, 2013 Janet A. Schlechte, M.D. Disclosure of Financial Relationships Janet A. Schlechte, M.D. has no relationships with any proprietary entity producing

More information

Drug Class Monograph

Drug Class Monograph Drug Class Monograph Class: Testosterone Hormone Replacement Drug: Androderm (testosterone transdermal system), Androgel (testosterone topical gel), Axiron (testosterone topical solution), Aveed (testosterone

More information

Testosterone Hormone Replacement Drug Class Prior Authorization Protocol

Testosterone Hormone Replacement Drug Class Prior Authorization Protocol Testosterone Hormone Replacement Drug Class Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective date: April 1, 2018 This policy has been developed through

More information

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY TESTOPEL- testosterone pellet Slate Pharma ---------- DESCRIPTION TESTOPEL Pellets (testosterone) are cylindrically shaped pellets 3.2mm (1/8 inch) in diameter and approximately 9mm in length. Each sterile

More information

Natural Hair Transplant Medical Center, Inc Dove Street, Suite #250, Newport Beach, CA Phone

Natural Hair Transplant Medical Center, Inc Dove Street, Suite #250, Newport Beach, CA Phone Natural Hair Transplant Medical Center, Inc. 1000 Dove Street, Suite #250, Newport Beach, CA 92660 Phone-949-622-6969 Finasteride (PROPECIA ) Acknowledgement Finasteride is an oral medication, manufactured

More information

DEPO-Testosterone Injection is available in two strengths, 100 mg/ml and 200 mg/ml testosterone cypionate.

DEPO-Testosterone Injection is available in two strengths, 100 mg/ml and 200 mg/ml testosterone cypionate. Depo -Testosterone testosterone cypionate injection, USP CIII DESCRIPTION DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate

More information

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

Medical Policy An independent licensee of the Blue Cross Blue Shield Association Androgens and Anabolic Steroids Page 1 of 53 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Androgens and Anabolic Steroids Prime Therapeutics will review Prior

More information

MI Androgen Deficiency Hypogonadism

MI Androgen Deficiency Hypogonadism MI Androgen Deficiency Hypogonadism WADA TUE Expert Group John A Lombardo, MD October 2014, Columbus, Ohio USA Hypothalamic-Pituitary-Gonadal Axis / 2 Hypogonadism/Androgen Deficiency Clinical syndrome:

More information

Inappropriate Testosterone Billings

Inappropriate Testosterone Billings Inappropriate Testosterone Billings Carla Patrick-Fagan March 30, 2015 Truven Health Analytics Inc. All Rights Reserved. 1 Agenda Proposed in the 2015 analytic plan Steroid prescriptions Code of Federal

More information

PRODUCT INFORMATION TESTOVIRON DEPOT. (testosterone enanthate)

PRODUCT INFORMATION TESTOVIRON DEPOT. (testosterone enanthate) PRODUCT INFORMATION TESTOVIRON DEPOT (testosterone enanthate) NAME OF THE MEDICINE Testosterone enanthate is designated chemically as 17 beta-heptanoyloxy-4-androstene-3- one. The empirical formula of

More information

The ICL Insider. Lab Testing: Testosterone. In This Issue. The Debate

The ICL Insider. Lab Testing: Testosterone. In This Issue. The Debate The ICL Insider February 2017 Volume 2, Issue 2 Lab Testing: Testosterone In This Issue Testosterone shashtilak@iclabs.ca Next Issue: Expected Release April 2017 The Debate Aging is accompanied by various

More information

MALE HORMONE THERAPY OPTIONS

MALE HORMONE THERAPY OPTIONS MALE HORMONE THERAPY OPTIONS The following tables have been compiled by Women s staff pharmacists to represent some of the more frequently prescribed regimens for men. The Women s logo is placed throughout

More information

TESTOFEN HUMAN CLINICAL TRIAL GENCOR PACIFIC, INC. Copyright 2006 by Gencor Pacific, Inc.

TESTOFEN HUMAN CLINICAL TRIAL GENCOR PACIFIC, INC. Copyright 2006 by Gencor Pacific, Inc. GENCOR PACIFIC, INC. 920 E. Orangethorpe Avenue, Suite B, Anaheim, CA 92801 Ph: 714.870.8723 714.870.8724 efax: 732.875.0306 drjit@gencorpacific.com gita@gencorpacific.com www.gencorpacific.com TESTOFEN

More information

Insight into male menopause'

Insight into male menopause' Insight into male menopause' Dr Mark Vanderpump MD FRCP Consultant Endocrinologist Clinics: Tuesday PM Mark Vanderpump Consultant Physician and Endocrinologist Introduction Serum total and free testosterone

More information

Androgenes and Antiandrogenes

Androgenes and Antiandrogenes Androgenes and Antiandrogenes Androgens The androgens are a group of steroids that have anabolic and/or masculinizing effects in both males and females. Testosterone [tess-toss-terone], the most important

More information

Secrets of Abang Sado : Effects of testosterone therapy. Azraai Nasruddin

Secrets of Abang Sado : Effects of testosterone therapy. Azraai Nasruddin + Secrets of Abang Sado : Effects of testosterone therapy Azraai Nasruddin + Testosterone Testosterone : Steroid hormone - Made primarily by the testicles in males - Small amounts produced by the adrenal

More information

September 17, FDA background documents for the discussion of two major issues in testosterone replacement therapy (TRT):

September 17, FDA background documents for the discussion of two major issues in testosterone replacement therapy (TRT): JOINT MEETING FOR BONE, REPRODUCTIVE AND UROLOGIC DRUGS ADVISORY COMMITTEE (BRUDAC) AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE (DSARM AC) September 17, 2014 FDA background documents for

More information

Medical Policy Testosterone Therapy

Medical Policy Testosterone Therapy Medical Policy Testosterone Therapy Subject: Testosterone Therapy Effective Date: April 2015 Overview: Testosterone cypionate, testosterone enanthate, testosterone undecanoate, and testosterone pellet

More information

MALE HORMONE THERAPY OPTIONS

MALE HORMONE THERAPY OPTIONS MALE HORMONE THERAPY OPTIONS The following tables have been compiled by Women s International Pharmacy staff pharmacists to represent some of the more frequently prescribed regimens for men. The Women

More information

Clinical Policy: Testosterone Reference Number: AZ.CP.PHAR.02 Effective Date: Last Review Date: Line of Business: Arizona Medicaid

Clinical Policy: Testosterone Reference Number: AZ.CP.PHAR.02 Effective Date: Last Review Date: Line of Business: Arizona Medicaid Clinical Policy: Reference Number: AZ.CP.PHAR.02 Effective Date: 11.16.16 Last Review Date: 09.12.18 Line of Business: Arizona Medicaid Revision Log See Important Reminder at the end of this policy for

More information

Health Products Regulatory Authority

Health Products Regulatory Authority 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Myodine 25 mg/ml solution for injection for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Nandrodine laurate 25

More information

TREATMENT OPTIONS FOR MALE HYPOGONADISM

TREATMENT OPTIONS FOR MALE HYPOGONADISM TREATMENT OPTIONS FOR MALE HYPOGONADISM Bruce Biundo, RPh, FACA PCCA Pharmacy Consulting Department Updated July 2012 Hypogonadism in men is primarily a state involving lower than expected levels of testosterone,

More information

PRODUCT INFORMATION PRIMOTESTON DEPOT. (testosterone enantate)

PRODUCT INFORMATION PRIMOTESTON DEPOT. (testosterone enantate) PRODUCT INFORMATION PRIMOTESTON DEPOT (testosterone enantate) NAME OF THE MEDICINE Testosterone enantate is designated chemically as 17 beta-heptanoyloxy-4-androstene-3- one. The empirical formula of testosterone

More information

Essential Standards. 8.ATOD.2 Understand the health risks associated with alcohol, tobacco, and other drug use.

Essential Standards. 8.ATOD.2 Understand the health risks associated with alcohol, tobacco, and other drug use. Essential Standards 8.ATOD.2 Understand the health risks associated with alcohol, tobacco, and other drug use. Clarifying Objective 8.ATOD.2.2 Evaluate the magnitude and likelihood of the risks associated

More information

1001 West Broadway, Vancouver, BC V6H 4B1. Topical Finasteride

1001 West Broadway, Vancouver, BC V6H 4B1. Topical Finasteride 1001 West Broadway, Vancouver, BC V6H 4B1 Topical Finasteride 1 Topical finasteride is a solution containing the drug finasteride typically sold under the brand names Propecia and Proscar. The Finasteride

More information

Dr Tarza Jamal Pharmacology Lecture 2

Dr Tarza Jamal Pharmacology Lecture 2 Contraceptives and androgen hormone Contraceptives: Currently, interference with ovulation is the most common pharmacologic intervention for preventing pregnancy. Major classes of contraceptives 1. Combination

More information

Male Hormone Replacement Therapy. Punita Dhindsa D.O PGY 2

Male Hormone Replacement Therapy. Punita Dhindsa D.O PGY 2 Male Hormone Replacement Therapy Punita Dhindsa D.O PGY 2 Physiology of Testosterone & Causes of Hypogonadism in Males The use of testosterone therapy is very common in the US, with an estimated 2.3 million

More information

Female testosterone level chart

Female testosterone level chart Female testosterone level chart The Borg System is 100 % Female testosterone level chart Mar 23, 2015. Male, Female. Age: T Level (ng/dl):, Age: T Level (ng/dl):. 0-5 mo. 75-400, 0-5 mo. 20-80. 6 mos.-9

More information

M0BCore Safety Profile. Pharmaceutical form(s)/strength: 5 mg SE/H/PSUR/0002/006 Date of FAR:

M0BCore Safety Profile. Pharmaceutical form(s)/strength: 5 mg SE/H/PSUR/0002/006 Date of FAR: M0BCore Safety Profile Active substance: Finasteride Pharmaceutical form(s)/strength: 5 mg P-RMS: SE/H/PSUR/0002/006 Date of FAR: 16.05.2014 4.3 Contraindications Finasteride is not indicated for use in

More information

Robert Perlstein, M.D. Medical Officer. Center for Drug Evaluation and Research. U.S. Food & Drug Administration

Robert Perlstein, M.D. Medical Officer. Center for Drug Evaluation and Research. U.S. Food & Drug Administration -------------------- Robert Perlstein, M.D. Medical Officer Center for Drug Evaluation and Research U.S. Food & Drug Administration -------------------- Sentencing of Food and Drug Offenses Before the

More information

Androgens and Anabolic Steroids Prior Authorization with Quantity Limit Through Preferred Topical Androgen Criteria Program Summary

Androgens and Anabolic Steroids Prior Authorization with Quantity Limit Through Preferred Topical Androgen Criteria Program Summary OBJECTIVE The intent of the Androgens and Anabolic Steroids Prior Authorization with Quantity Limit (PA) program is to appropriately select patients for therapy according to product labeling and/or clinical

More information

Affirming Care of the Transgender Patient

Affirming Care of the Transgender Patient Mountain West AIDS Education and Training Center Affirming Care of the Transgender Patient Jessica Rongitsch, MD, FACP This presentation is intended for educational use only, and does not in any way constitute

More information

Monitoring Hormone Therapy Mark Newman, M.S. President of Precision Analytical Inc.

Monitoring Hormone Therapy Mark Newman, M.S. President of Precision Analytical Inc. Mr Mark Newman Monitoring Hormone Therapy Mark Newman, M.S. President of Precision Analytical Inc. 2 Avoiding Pitfalls in (B)HRT Monitoring and Picking the Right Lab Test Objectives: Outline how expected

More information

The Testosterone Quandary. Beth Crowder, PhD, APRN

The Testosterone Quandary. Beth Crowder, PhD, APRN The Testosterone Quandary Beth Crowder, PhD, APRN Objectives Define testosterone, the hypothalamic-pituitary-gonadotrophic axis, and normal blood levels List functions of testosterone and symptoms of low

More information

NEW ZEALAND DATA SHEET

NEW ZEALAND DATA SHEET NEW ZEALAND DATA SHEET 1. PRODUCT NAME DEPO-TESTOSTERONE 100mg/mL Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml solution for injection contains 100 mg/ml testosterone cypionate.

More information

Jeremiah Murphy, MD Mercy Urology Clinic. October 21, 2017

Jeremiah Murphy, MD Mercy Urology Clinic. October 21, 2017 Jeremiah Murphy, MD Mercy Urology Clinic October 21, 2017 Describe an appropriate strategy for the evaluation and diagnosis of male hypogonadism Endocrine Society Clinical Practice Guideline-2010 Review

More information

Natural estrogens estradiol estrone estriol

Natural estrogens estradiol estrone estriol Estrogens Natural estrogens estradiol estrone estriol Nonsteroidal synthetic Diethylstilbestrol Chlorotrianisene Methallenestril Steroidal synthetic Ethinyl estradiol Mestranol Quinestrol To decrease some

More information

Current Data and Considerations Novel Testosterone Formulations

Current Data and Considerations Novel Testosterone Formulations Current Data and Considerations Novel Testosterone Formulations 1 Current and Novel Therapeutic Options Module 4 2 Objectives Identify desirable characteristics of ideal testosterone formulations Review

More information

Adverse effects of anabolic androgenic steroids abuse on gonadal function, glucose homeostasis and cardiovascular function

Adverse effects of anabolic androgenic steroids abuse on gonadal function, glucose homeostasis and cardiovascular function Adverse effects of anabolic androgenic steroids abuse on gonadal function, glucose homeostasis and cardiovascular function Associate Professor Caroline Kistorp, Ph.D Department of Internal Medicine, Herlev

More information

All About T Testosterone for FTMs. Presented by John Otto, MLIS

All About T Testosterone for FTMs. Presented by John Otto, MLIS All About T Testosterone for FTMs Presented by John Otto, MLIS Who? Anyone thinking about transitioning Those who have transitioned, but want to know more Empowerment from self-managing transition Allies

More information

XYOSTED (testosterone enanthate) injection, for subcutaneous use CIII Initial US approval: 1953 IMPORTANT SAFETY INFORMATION

XYOSTED (testosterone enanthate) injection, for subcutaneous use CIII Initial US approval: 1953 IMPORTANT SAFETY INFORMATION ANTARES PHARMA ANNOUNCES THE COMMERCIAL AVAILABILITY OF XYOSTED (TESTOSTERONE ENANTHATE) INJECTION A NEW TREATMENT FOR ADULT MEN DIAGNOSED WITH TESTOSTERONE DEFICIENCY XYOSTED - A Novel Subcutaneous Testosterone

More information

Month/Year of Review: September 2013 Date of Last Review: December 2009

Month/Year of Review: September 2013 Date of Last Review: December 2009 Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119 Copyright 2013 Oregon State University. All Rights

More information

Donald W. Morrish, MD, PhD, FRCPC Presented at Mountain Man: Men's Health Conference, May Terry s Testosterone

Donald W. Morrish, MD, PhD, FRCPC Presented at Mountain Man: Men's Health Conference, May Terry s Testosterone Focus on CME at University of Alberta ADAM: Dealing with the Decline Donald W. Morrish, MD, PhD, FRCPC Presented at Mountain Man: Men's Health Conference, May 2005 We now know there is a decline in total

More information

HAIR LOSS HORMONE IMBALANCE HAIR LOSS HORMONE IMBALANCE PDF HAIR LOSS - WIKIPEDIA HORMONE IMBALANCE CHECKLIST - WEIGHT LOSS PROGRAMS

HAIR LOSS HORMONE IMBALANCE HAIR LOSS HORMONE IMBALANCE PDF HAIR LOSS - WIKIPEDIA HORMONE IMBALANCE CHECKLIST - WEIGHT LOSS PROGRAMS PDF HAIR LOSS - WIKIPEDIA HORMONE IMBALANCE CHECKLIST - WEIGHT LOSS PROGRAMS 1 / 6 2 / 6 3 / 6 hair loss hormone imbalance pdf Male pattern hair loss is believed to be due to a combination of genetics

More information

Icd-10 low levels of testosterone

Icd-10 low levels of testosterone Icd-10 low levels of testosterone The Borg System is 100 % Icd-10 low levels of testosterone 1-10-2017 if your hormone levels are too high or too low, you may have a hormone disorder. Hormone diseases

More information

Gynaecomastia. Benign breast conditions information provided by Breast Cancer Care

Gynaecomastia. Benign breast conditions information provided by Breast Cancer Care Gynaecomastia This booklet tells you about gynaecomastia. It explains what gynaecomastia is, what causes it, how it s diagnosed and what will happen if it needs to be treated or followed up. Benign breast

More information

Original Research Declining testicular function in aging men

Original Research Declining testicular function in aging men (2003) 15, Suppl 4, S3 S8 & 2003 Nature Publishing Group All rights reserved 0955-9930/03 $25.00 www.nature.com/ijir Original Research 1 * 1 Wesley Woods Health Center, Atlanta, Georgia, USA Age-related

More information

TESTOFEN. Anabolic & Androgenic Activity GENCOR PACIFIC, INC. Fenugreek Extract standardized for FENUSIDE TM. Copyright 2005 by Gencor Pacific, Inc.

TESTOFEN. Anabolic & Androgenic Activity GENCOR PACIFIC, INC. Fenugreek Extract standardized for FENUSIDE TM. Copyright 2005 by Gencor Pacific, Inc. GENCOR PACIFIC, INC. 920E. Orangethorpe Avenue, Suite B, Anaheim, CA. 92801 Ph: 714.870.8723 714.870.8724 efax: 732.875.0306 drjit@gencorpacific.com manu@gencorpacific.com www.gencorpacific.com TESTOFEN

More information

Male pattern baldness is the most common type of balding among males. It affects roughly, 50% of men by the age of 50,

Male pattern baldness is the most common type of balding among males. It affects roughly, 50% of men by the age of 50, Dihydrotestosterone (DHT) Male pattern baldness is the most common type of balding among males. It affects roughly, 30% of men by the age of 30, 50% of men by the age of 50, 57% of men by the age of 60.

More information

Elements for a Public Summary. Overview of disease epidemiology

Elements for a Public Summary. Overview of disease epidemiology VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Benign prostatic hyperplasia (BPH) (an increase in size of the prostate that is not cancerous) is the most prevalent of all diseases

More information

Package Leaflet: Information for the patient. Sustanon 250, 250 mg/ml, solution for injection (testosterone esters)

Package Leaflet: Information for the patient. Sustanon 250, 250 mg/ml, solution for injection (testosterone esters) Package Leaflet: Information for the patient Sustanon 250, 250 mg/ml, solution for injection (testosterone esters) Read all of this leaflet carefully before you start using this medicine because it contains

More information

Reproductive DHT Analyte Information

Reproductive DHT Analyte Information Reproductive DHT Analyte Information - 1 - DHT Introduction Dihydrotestosterone (DHT) together with other important steroid hormones such as testosterone, androstenedione (ASD) and dehydroepiandrosterone

More information

Formally known as anabolic steroids or anabolic-androgenic steroids, but they are sometimes called 'roids', 'gear' or 'juice'.

Formally known as anabolic steroids or anabolic-androgenic steroids, but they are sometimes called 'roids', 'gear' or 'juice'. Steroids What are steroids? Steroids are drugs that help the growth and repair of muscle tissue. They are synthetic hormones that imitate male sex hormones, specifically testosterone. Steroids can increase

More information

Creatine Versus Anabolic Steroids. Over the past few years, many athletes have been using performance-enhancing

Creatine Versus Anabolic Steroids. Over the past few years, many athletes have been using performance-enhancing Hester 1 Kyle Hester Instructor s Name ENGL 1013 Date Creatine Versus Anabolic Steroids Over the past few years, many athletes have been using performance-enhancing supplements on a regular basis. Two

More information

Elements for a public summary

Elements for a public summary VI.2 VI.2.1 Elements for a public summary Overview of disease epidemiology Prostate gland enlargement is a common condition as men get older. Also called benign prostatic hyperplasia (BPH) and prostatic

More information

*Dr. Mushreq Aziz Tnesh AL-Lamy, **Dr. Asaad Adnan Aziz Al-Safi. *, ** Physical Education College /Al-Qadisiyah University ABSTRACT

*Dr. Mushreq Aziz Tnesh AL-Lamy, **Dr. Asaad Adnan Aziz Al-Safi. *, ** Physical Education College /Al-Qadisiyah University ABSTRACT EFFECT OF THE ABUSE OF STEROIDAL ANDRO- GENIC HORMONES AND THEIR RELATIVE CONTRI- BUTION TO THE LEVEL OF HORMONES (TESTOS- TERONE, FSH, LH) AND THE PROPORTION OF IN- FERTILITY IN BODYBUILDERS *Dr. Mushreq

More information

Chapter 5. General discussion

Chapter 5. General discussion Chapter 5. General discussion 127 Chapter 5 In 2003, two review papers concluded that endogenous androgens do not show any consistent association with cardiovascular disease (CVD) risk 1,2. Apparently,

More information

HGH for Sale Human Growth Hormone

HGH for Sale Human Growth Hormone HGH for Sale Human Growth Hormone Many people consider HGH for sale, or Human Growth Hormone (C 990 H 1529 N 263 O 299 S 7 ) the fountain of youth. In fact, many experts suggest that this is the most sought-after

More information

Androgens and Anabolic Steroids Prior Authorization and Quantity Limit Program Summary

Androgens and Anabolic Steroids Prior Authorization and Quantity Limit Program Summary Androgens and Anabolic Steroids Prior Authorization and Quantity Limit Program Summary FDA APPROVED INDICATIONS DOSAGE 1-11,27,28,32,33,37-39,41,42,46,50 Topical Androgen Agents Agent Indication Dosage

More information

TESTIM (testosterone gel) for topical use, CIII Initial U.S. Approval: 1953

TESTIM (testosterone gel) for topical use, CIII Initial U.S. Approval: 1953 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TESTIM safely and effectively. See full prescribing information for TESTIM. TESTIM (testosterone

More information

Testosterone Effects in Transmen

Testosterone Effects in Transmen Transmen Testosterone Effects in Transmen EFFECT Skin oiliness/acne Facial/body hair growth Scalp hair loss Increased muscle mass/strength Fat redistribution Cessation of menses Clitoral enlargement Vaginal

More information

FINASTERIDE (PROPECIA, PROSCAR) SIDE EFFECT & CONSENT FORM

FINASTERIDE (PROPECIA, PROSCAR) SIDE EFFECT & CONSENT FORM 750 West Broadway Street Suite 905 Vancouver, BC M5Z 1K1 FAX: (604) 648-9003 vancouveroffice@donovanmedical.com FINASTERIDE (PROPECIA, PROSCAR) SIDE EFFECT & CONSENT FORM What is finasteride? Finasteride

More information

Are Steroids Worth the Risk?

Are Steroids Worth the Risk? Are Steroids Worth the Risk? Dominic has baseball on the brain. Just being good isn't enough he wants to be the best. He dreams of playing in the majors someday, but worries about the intense competition

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. FINASTERIDE 1 MG FILM-COATED TABLETS (finasteride)

PACKAGE LEAFLET: INFORMATION FOR THE USER. FINASTERIDE 1 MG FILM-COATED TABLETS (finasteride) PACKAGE LEAFLET: INFORMATION FOR THE USER FINASTERIDE 1 MG FILM-COATED TABLETS (finasteride) Read all of this leaflet carefully before you start taking this medicine because it contains important information

More information

Although women produce only

Although women produce only For mass reproduction, content licensing and permissions contact Dowden Health Media. Mary Lake Polan, MD, PhD, MPH Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Chair Emeritus,

More information

Icd 10 hormone replacement therapy male

Icd 10 hormone replacement therapy male Icd 10 hormone replacement therapy male 2018 ICD - 10 code for Hormone replacement therapy is Z79.890. Lookup the complete ICD 10 Code details for Z79.890. The ICD - 10 system requires that. TEENren who

More information

Athletics Australia Transgender Policy

Athletics Australia Transgender Policy Athletics Australia Transgender Policy Policy Transgender Policy Eligibility of Athletes who have undergone sex reassignment to compete in women s competition. Related Policies Member Protection Policy,

More information

HGH for Sale Natural Anti-Aging Human Growth Hormone

HGH for Sale Natural Anti-Aging Human Growth Hormone HGH for Sale Natural Anti-Aging Human Growth Hormone Human growth hormone is one of the hottest supplement trends on the market, and now you can purchase top-quality HGH to be delivered right to your home!

More information

Updates on Anti-doping and TUE Management in Paralympic Sport

Updates on Anti-doping and TUE Management in Paralympic Sport International Paralympic Committee Updates on Anti-doping and TUE Management in Paralympic Sport Matthew Fedoruk, Ph.D. March 15, 2018 PyeongChang 2018 IPC Medical / Sports Science Committee Workshops

More information

HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use testosterone gel safely and effectively. See full prescribing information for testosterone gel. Testosterone

More information

Use of Performance Enhancing Substances Good Chemistry Gone Bad. Evan M. Klass, M.D., F.A.C.P.

Use of Performance Enhancing Substances Good Chemistry Gone Bad. Evan M. Klass, M.D., F.A.C.P. Use of Performance Enhancing Substances 2017 Good Chemistry Gone Bad Evan M. Klass, M.D., F.A.C.P. Doping the use of banned athletic performance-enhancing drugs by competitors Performance enhancing substances

More information

Shared Care Guideline For Prescribing Sustanon 250 to boys with Constitutional Delay of Growth and Puberty (CDGP)

Shared Care Guideline For Prescribing Sustanon 250 to boys with Constitutional Delay of Growth and Puberty (CDGP) East Kent Prescribing Group Shared Care Guideline For Prescribing Sustanon 250 to boys with Constitutional Delay of Growth and Puberty (CDGP) Recommendations: The following shared care for managing the

More information

LIFETIME FITNESS HEALTHY NUTRITION. UNIT 2 Lesson 14 FLEXIBILITY LEAN BODY COMPOSITION

LIFETIME FITNESS HEALTHY NUTRITION. UNIT 2 Lesson 14 FLEXIBILITY LEAN BODY COMPOSITION LIFETIME FITNESS HEALTHY NUTRITION MUSCULAR STRENGTH AEROBIC ENDURANCE UNIT 2 Lesson 14 FLEXIBILITY LEAN BODY COMPOSITION MUSCULAR ENDURANCE Created by Derek G. Becher B.P.E., B. Ed., AFLCA Resistance

More information

PRODUCT INFORMATION PROVIRON

PRODUCT INFORMATION PROVIRON PRODUCT INFORMATION PROVIRON NAME OF TE MEDICINE Mesterolone is a white to yellowish crystalline powder and is practically insoluble in water. The chemical name for mesterolone is 17 beta-ydroxy-1 alpha-methyl-5

More information

See Important Reminder at the end of this policy for important regulatory and legal information.

See Important Reminder at the end of this policy for important regulatory and legal information. Clinical Policy: (Human, Recombinant) Reference Number: CP.CPA.76 Effective Date: 11.16.16 Last Review Date: 08.17 Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder at the end of

More information

The Science of. NUTRICULA Longevity Journal

The Science of. NUTRICULA Longevity Journal 32 December, 2011 The Science of 33 NUTRICULA Longevity Journal As men age, there is often a decline in libido and sexual function. This decline frequently interferes in intimacy within romantic relationships,

More information

The physiology of normal androgen production in

The physiology of normal androgen production in Mayo Clin Proc, April 2004, Vol 79 (Supplement) Formulations and Use of Androgens S3 Supplement Article Formulations and Use of Androgens in Women MICHELINE C. CHU, MD, AND ROGERIO A. LOBO, MD The physiology

More information

TESTOSTERONE gel, for topical use, CIII Initial U.S. Approval: 1953

TESTOSTERONE gel, for topical use, CIII Initial U.S. Approval: 1953 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TESTOSTERONE gel safely and effectively. See full prescribing information for TESTOSTERONE gel. TESTOSTERONE

More information

Pros and Cons of Hormone Testing in Different Body Fluids with Different Routes of Hormone Delivery

Pros and Cons of Hormone Testing in Different Body Fluids with Different Routes of Hormone Delivery Pros and Cons of Hormone Testing in Different Body Fluids with Different Routes of Hormone Delivery David T Zava, PhD ZRT laboratory A Guide to Steroid Hormone Testing in Different Body Fluids Following

More information

Cpt code for testosterone cypionate injection

Cpt code for testosterone cypionate injection Cpt code for testosterone cypionate injection As the number of people taking injections. Number: 0007. Policy. Aetna considers the diagnosis and treatment of erectile dysfunction (impotence) medically

More information

Pathways and manipulation of testosterone biosynthesis and metabolism

Pathways and manipulation of testosterone biosynthesis and metabolism Pathways and manipulation of testosterone biosynthesis and metabolism Dihydrotestosterone 8% Pregnenolone 3-βSD Progesterone 17- Pregnenolone 17a--lase 17-Progesterone 3-βSD 17a--lase Androstenedione DEA

More information

Antiduretic Hormone, Growth. Hormone & Anabolic Steroids

Antiduretic Hormone, Growth. Hormone & Anabolic Steroids Goudarz Sadeghi, DVM, PhD, DSc Associate Professor of Pharmacology University of Tehran Faculty of Veterinary Medicine Veterinary Pharmacology Endocrine System Antiduretic Hormone, Growth Hormone & Anabolic

More information

CONFÉRENCE À SUCCÈS EN SCIENCES DE LA VIE : ENDOCEUTICS

CONFÉRENCE À SUCCÈS EN SCIENCES DE LA VIE : ENDOCEUTICS CONFÉRENCE À SUCCÈS EN SCIENCES DE LA VIE : ENDOCEUTICS 13 Septembre 2018 Quebec, Canada 1 ENDOCEUTICS No. 1 Innovative pharmaceutical company in menopausal women s health in the world 2 Facilities Head

More information

What is the difference with Whey, Casein, BCAA's, Glutamine, NO products?

What is the difference with Whey, Casein, BCAA's, Glutamine, NO products? Charles Glass - Mr. World / IFBB PRO Senior Executive Vice President Personal Trainers Association (PROPTA) PROPTA Master Trainer about Recov Bipeptides This is the best protein supplement I ever tried

More information

LJMU Research Online

LJMU Research Online LJMU Research Online Kimergård, A, Breindahl, T, Hindersson, P and McVeigh, J The composition of anabolic steroids from the illicit market is largely unknown: implications for clinical case reports (Commentary)

More information

AndroGel. (testosterone gel) 1% H 3 C

AndroGel. (testosterone gel) 1% H 3 C 1 AndroGel (testosterone gel) 1% 500122/500127 Rev Dec 2004 DESCRIPTION AndroGel (testosterone gel) is a clear, colorless hydroalcoholic gel containing 1% testosterone. AndroGel provides continuous transdermal

More information

See 17 for PATIENT COUNSELING INFORMATION and Medication o 50 mg/0.5 ml. Revised: 09/2018 o 100 mg/0.5 ml

See 17 for PATIENT COUNSELING INFORMATION and Medication o 50 mg/0.5 ml. Revised: 09/2018 o 100 mg/0.5 ml HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XYOSTED safely and effectively. See full prescribing information for XYOSTED. XYOSTED (testosterone

More information